Reimbursement & Market Access
175 articles
Saudi Arabia SFDA Registered Devices Teardown & Channel Map
A database teardown of the 163,185 medical devices registered under Saudi Arabia's SFDA, detailing MDMA risk class splits, manufacturer concentration, and AR lock-in risks.
Algeria MIPH Medical Device Import Teardown: 327 Approved Importers
A quantitative teardown of Algeria's MIPH list of 327 approved medical device importers, analyzing the SARL-dominated legal mix and Decree 24/22 reforms.
Morocco AMMPS Medical Device Establishment Teardown: 171 Declared Entities
An analysis of Morocco's AMMPS list of 171 declared medical device establishments, exploring why MNCs enter via local partners and Law 10.22 changes.
Chile ISP Registered Devices Teardown & Channel Map
A registry analysis of the 619 devices registered under Chile's ISP decree-controlled families, covering condom and syringe category skews, manufacturer countries, and titular concentration.
Oman MOH Registered Devices Teardown & Class C/D Transition
A data teardown of the 502 medicated devices on the Oman MOH register, detailing the dermatology and ophthalmology category skews, local agent concentration, and the new Class C/D mandate.
Pakistan DRAP Registered Medical Devices Teardown & 2025 Ramp
A quantitative analysis of the 12,666 medical devices registered under Pakistan's DRAP, detailing the Class A-D splits, local-vs-import manufacturer mix, and the 2025 registration surge.
Albania AKBPM Medical Device Registry Teardown: Manufacturers & LTRs
A data-driven teardown of Albania's AKBPM register. Analyze the risk-class split, category mix, manufacturer landscape, and distributor concentration.
Kenya PPB Retained Medical Devices Teardown: Manufacturers & LTRs
A data-driven teardown of Kenya's PPB retained medical devices register. Analyze the manufacturer landscape and local technical representative concentration.
Zambia ZAMRA Medical Device Registry Teardown: Manufacturers & LTRs
A data-driven teardown of Zambia's ZAMRA medical device and IVD registry. Explore risk-class splits, country of origin trends, and LRP channel concentration.
Mindray Worldwide Market-Access Footprint: 24-Market Registry Teardown
A comprehensive database analysis detailing Mindray's 6,620 distinct registrations across 24 global markets, including patient monitoring accessories, IVD, and ultrasound segments.
Philips Worldwide Regulatory and Safety Footprint: 26-Market Registry Teardown
A comprehensive database analysis detailing Philips' 7,909 distinct registrations across 26 global markets, integrated with clinical trial data and patent portfolios.
Siemens Healthineers Global Regulatory Footprint: 28-Market Registry Breakdown
A comprehensive database analysis detailing Siemens Healthineers' 18,956 distinct registrations across 28 global markets, including IVD, imaging, and oncology segments.
China NMPA Device Registration: 14,187 Approvals, Import Mix, and Foreign Wins
A data-driven analysis of China's NMPA medical device registry database. Discover approval volumes, import vs. domestic splits, and strategic pathways for foreign device makers.
Abbott FDA Device Footprint: Diagnostics, Recalls & PMA Portfolio
A data-driven regulatory profile of Abbott's FDA clearances, PMA approvals, safety recalls, diagnostics division, and global manufacturing hubs in Illinois, California, Germany, and the Netherlands.
Boston Scientific FDA Footprint: PMA, 510(k) & Recall Patterns
A data-driven regulatory profile of Boston Scientific's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs in Minnesota, Rhode Island, Massachusetts, and Ireland.
Gambia MCA Medical Device Registry: Registered Products & Compliance Trends
A comprehensive, data-driven analysis of the Gambia Medicines Control Agency (MCA) medical device registry. Explore manufacturer origins, leading suppliers, and compliance trends.
GE HealthCare FDA Device Footprint: Clearances, PMA & Recalls Guide
A data-driven regulatory profile of GE HealthCare's FDA clearances, PMA approvals, safety recalls, and offshore manufacturing hubs in India, Mexico, and Finland.
Ghana FDA Medical Device Registry: Classifications, Importers & Countries
A comprehensive, data-driven analysis of the Ghana Food and Drugs Authority (FDA) medical device registry. Explore risk classifications, local agents, and manufacturing origins.
Medtronic FDA Device Footprint: PMA, 510(k) & Recall Analysis
A data-driven regulatory profile of Medtronic's FDA clearances, massive PMA database footprint, safety recalls, and global manufacturing hubs in Memphis, Puerto Rico, Costa Rica, and India.
Philips FDA Device Footprint: Clearances, Recalls & Consent Decree
A comprehensive regulatory dossier analyzing Philips' FDA clearances, cardiovascular PMA distribution, recall history under the 2024 consent decree, and global manufacturing plants.